RELENZA (Page 5 of 6)

14.2 Prophylaxis of Influenza

The efficacy of RELENZA in preventing naturally occurring influenza illness has been demonstrated in 2 post-exposure prophylaxis studies in households and 2 seasonal prophylaxis studies during community outbreaks of influenza. The primary efficacy endpoint in these studies was the incidence of symptomatic, laboratory-confirmed influenza, defined as the presence of 2 or more of the following symptoms: oral temperature ≥100°F/37.8°C or feverishness, cough, headache, sore throat, and myalgia; and laboratory confirmation of influenza A or B by culture, PCR, or seroconversion (defined as a 4-fold increase in convalescent antibody titer from baseline).

Household Prophylaxis Studies: Two studies assessed post-exposure prophylaxis in household contacts of an index case. Within 1.5 days of onset of symptoms in an index case, each household (including all family members ≥5 years of age) was randomized to RELENZA 10 mg inhaled once daily or placebo inhaled once daily for 10 days. In the first study only, each index case was randomized to RELENZA 10 mg inhaled twice daily for 5 days or inhaled placebo twice daily for 5 days. In this study, the proportion of households with at least 1 new case of symptomatic laboratory-confirmed influenza was reduced from 19.0% (32 of 168 households) for the placebo group to 4.1% (7 of 169 households) for the group receiving RELENZA.

In the second study, index cases were not treated. The incidence of symptomatic laboratory-confirmed influenza was reduced from 19.0% (46 of 242 households) for the placebo group to 4.1% (10 of 245 households) for the group receiving RELENZA.

Seasonal Prophylaxis Studies: Two seasonal prophylaxis studies assessed RELENZA 10 mg inhaled once daily versus placebo inhaled once daily for 28 days during community outbreaks. The first study enrolled subjects 18 years of age or greater (mean age 29 years) from 2 university communities. The majority of subjects were unvaccinated (86%). In this study, the incidence of symptomatic laboratory-confirmed influenza was reduced from 6.1% (34 of 554) for the placebo group to 2.0% (11 of 553) for the group receiving RELENZA.

The second seasonal prophylaxis study enrolled subjects 12 to 94 years of age (mean age 60 years) with 56% of them older than 65 years of age. Sixty-seven percent of the subjects were vaccinated. In this study, the incidence of symptomatic laboratory-confirmed influenza was reduced from 1.4% (23 of 1,685) for the placebo group to 0.2% (4 of 1,678) for the group receiving RELENZA.

16 HOW SUPPLIED/STORAGE AND HANDLING

RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device.

They are supplied by Dispensing Solutions Inc. as follows:

NDC Strength Quantity/Form Source NDC
68258-3030-1 5 mg 5 Rotadisks containing 4 Blisters 0173-0681-01

This product was Manufactured By:

GlaxoSmithKline
Research Triangle Park, NC 27709
Made in UK

And Relabeled By:

Dispensing Solutions Inc.
3000 West Warner Ave
Santa Ana, CA 92704
United States

Store at 25 °C (77 °F); excursions permitted to 15 ° to 30 °C (59 ° to 86 °F) (see USP Controlled Room Temperature). Keep out of reach of children. Do not puncture any RELENZA ROTADISK blister until taking a dose using the DISKHALER.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling provided as a separate leaflet accompanying the product.

17.1 Bronchospasm

Patients should be advised of the risk of bronchospasm, especially in the setting of underlying airways disease, and should stop RELENZA and contact their physician if they experience increased respiratory symptoms during treatment such as worsening wheezing, shortness of breath, or other signs or symptoms of bronchospasm [see Warnings and Precautions (5.1)] . If a decision is made to prescribe RELENZA for a patient with asthma or chronic obstructive pulmonary disease, the patient should be made aware of the risks and should have a fast-acting bronchodilator available.

17.2 Concomitant Bronchodilator Use

Patients scheduled to take inhaled bronchodilators at the same time as RELENZA should be advised to use their bronchodilators before taking RELENZA.

17.3 Neuropsychiatric Events

Patients with influenza (the flu), particularly children and adolescents, may be at an increased risk of seizures, confusion, or abnormal behavior early in their illness. These events may occur after beginning RELENZA or may occur when flu is not treated. These events are uncommon but may result in accidental injury to the patient. Therefore, patients should be observed for signs of unusual behavior and a healthcare professional should be contacted immediately if the patient shows any signs of unusual behavior [see Warnings and Precautions (5.3)].

17. 4 Instructions for Use

Patients should be instructed in use of the delivery system. Instructions should include a demonstration whenever possible. For the proper use of RELENZA, the patient should read and follow carefully the accompanying Patient Instructions for Use.

If RELENZA is prescribed for children, it should be used only under adult supervision and instruction, and the supervising adult should first be instructed by a healthcare professional [see Dosage and Administration (2.1)].

17.5 Risk of Influenza Transmission to Others

Patients should be advised that the use of RELENZA for treatment of influenza has not been shown to reduce the risk of transmission of influenza to others.

RELENZA, DISKHALER, and ROTADISK are registered trademarks of GlaxoSmithKline.

GlaxoSmithKline
Research Triangle Park, NC 27709

©2009, GlaxoSmithKline. All rights reserved.

PATIENT LABELING

RELENZA® (zanamivir) Inhalation Powder

This leaflet contains important patient information about RELENZA (zanamivir) Inhalation Powder, and should be read completely before beginning treatment. It does not, however, take the place of discussions with your healthcare provider about your medical condition or your treatment. This summary does not list all benefits and risks of RELENZA. The medication described here can only be prescribed and dispensed by a licensed healthcare provider, who has information about your medical condition and more information about the drug, including how to take it, what to expect, and potential side effects. If you have any questions about RELENZA, talk with your healthcare provider.

What is RELENZA?

RELENZA (ruh-LENS-uh) is a medicine for the treatment of influenza (flu, infection caused by influenza virus) and for reducing the chance of getting the flu in community and household settings. It belongs to a group of medicines called neuraminidase inhibitors. These medications attack the influenza virus and prevent it from spreading inside your body. RELENZA treats the cause of influenza at its source, rather than simply masking the symptoms.

Important Safety Information About RELENZA

Some patients have had bronchospasm (wheezing) or serious breathing problems when they used RELENZA. Many but not all of these patients had previous asthma or chronic obstructive pulmonary disease. RELENZA has not been shown to shorten the duration of influenza in people with these diseases. Because of the risk of side effects and because it has not been shown to help them, RELENZA is not recommended for people with chronic respiratory disease such as asthma or chronic obstructive pulmonary disease.

If you develop worsening respiratory symptoms such as wheezing or shortness of breath, stop using RELENZA and contact your healthcare provider right away.

If you have chronic respiratory disease such as asthma and chronic obstructive pulmonary disease and your healthcare provider has prescribed RELENZA, you should have a fast-acting, inhaled bronchodilator available for your use. If you are scheduled to use an inhaled bronchodilator at the same time as RELENZA, use the inhaled bronchodilator before using RELENZA.

Read the rest of this leaflet for more information about side effects and risks.

Other kinds of infections can appear like influenza or occur along with influenza, and need different kinds of treatment. Contact your healthcare provider if you feel worse or develop new symptoms during or after treatment, or if your influenza symptoms do not start to get better.

Who should not take RELENZA?

RELENZA is not recommended for people who have chronic lung disease such as asthma or chronic obstructive pulmonary disease. RELENZA has not been shown to shorten the duration of influenza in people with these diseases, and some people have had serious side effects of bronchospasm and worsening lung function. (See the section of this Patient Information entitled “Important Safety Information About RELENZA.”)

You should not take RELENZA if you are allergic to zanamivir or any other ingredient of RELENZA. Also tell your healthcare provider if you have any type of chronic condition including lung or heart disease, if you are allergic to any other medicines or food products, or if you are pregnant.

RELENZA was not effective in reducing the chance of getting the flu in 2 studies in nursing home patients.

RELENZA does not treat flu-like illness that is not caused by influenza virus.

Who should consider taking RELENZA?

Adult and pediatric patients at least 7 years of age who have influenza symptoms that appeared within the previous day or two. Typical symptoms of influenza include sudden onset of fever, cough, headache, fatigue, muscular weakness, and sore throat.

RELENZA can also help reduce the chance of getting the flu in adults and children at least 5 years of age who have a higher chance of getting the flu because they spend time with someone who has the flu. RELENZA can also reduce the chance of getting the flu if there is a flu outbreak in the community.

The use of RELENZA for the treatment of flu has not been shown to reduce the risk of spreading the virus to others.

Can I take other medications with RELENZA?

RELENZA has been shown to have an acceptable safety profile when used as labeled, with minimal risk of drug interactions. Your healthcare provider may recommend taking other medications, including over-the-counter medications, to reduce fever or other symptoms while you are taking RELENZA. Before starting treatment, make sure that your healthcare provider knows if you are taking other medicines. If you are scheduled to use an inhaled bronchodilator at the same time as RELENZA, you should use the inhaled bronchodilator before using RELENZA.

Before taking RELENZA, please let your healthcare provider know if you received live attenuated influenza vaccine (FLUMIST®) intranasal in the past 2 weeks.

How and when should I take RELENZA?

RELENZA is packaged in medicine disks called ROTADISKS® and is inhaled by mouth using a delivery device called a DISKHALER®. Each ROTADISK contains 4 blisters. Each blister contains 5 mg of active drug and 20 mg of lactose powder (which contains milk proteins).

You should receive a demonstration on how to use RELENZA in the DISKHALER from a healthcare provider. Before taking RELENZA, read the “Patient Instructions for Use.” Make sure that you understand these instructions and talk to your healthcare provider if you have any questions. Children who use RELENZA should always be supervised by an adult who understands how to use RELENZA. Proper use of the DISKHALER to inhale the drug is necessary for safe and effective use of RELENZA.

If you have the flu the usual dose for treatment is 2 inhalations of RELENZA (1 blister per inhalation) twice daily (in the morning and evening) for 5 days. It is important that you begin your treatment with RELENZA as soon as possible from the first appearance of your flu symptoms. Take 2 doses on the first day of treatment whenever possible if there are at least 2 hours between doses.

To reduce the chance of getting the flu, the usual dose is 2 inhalations of RELENZA (1 blister per inhalation) once daily for 10 or 28 days as prescribed by your healthcare provider.

Never share RELENZA with anyone, even if they have the same symptoms. If you feel worse or develop new symptoms during treatment with RELENZA, or if your flu symptoms do not start to get better, stop using the medicine and contact your healthcare provider.

What if I miss a dose?

If you forget to take your medicine at any time, take the missed dose as soon as you remember, except if it is near the next dose (within 2 hours). Then continue to take RELENZA at the usual times. You do not need to take a double dose. If you have missed several doses, inform your healthcare provider and follow the advice given to you.

What are important or common possible side effects of taking RELENZA?

Some patients have had breathing problems while taking RELENZA. This can be very serious and need treatment right away. Most of the patients who had this problem had asthma or chronic obstructive pulmonary disease, but some did not. If you have trouble breathing or have wheezing after your dose of RELENZA, stop taking RELENZA and get medical attention.

In studies, the most common side effects with RELENZA have been headaches; diarrhea; nausea; vomiting; nasal irritation; bronchitis; cough; sinusitis; ear, nose, and throat infections; and dizziness. Other side effects that have been reported, but were not as common, include rashes and allergic reactions, some of which were severe.

People with influenza (the flu), particularly children and adolescents, may be at an increased risk of seizures, confusion, or abnormal behavior early in their illness. These events may occur after beginning RELENZA or may occur when flu is not treated. These events are uncommon but may result in accidental injury to the patient. Therefore, patients should be observed for signs of unusual behavior and a healthcare professional should be contacted immediately if the patient shows any signs of unusual behavior.

This list of side effects is not complete. Your healthcare provider or pharmacist can discuss with you a more complete list of possible side effects with RELENZA. Talk to your healthcare provider promptly about any side effects you have.

Please refer to the section entitled “Important Safety Information About RELENZA” for additional information.

Should I get a flu shot?

RELENZA is not a substitute for a flu shot. You should receive an annual flu shot according to guidelines on immunization practices that your healthcare provider can share with you.

What if I am pregnant or nursing?

If you are pregnant or planning to become pregnant while taking RELENZA, talk to your healthcare provider before taking this medication. RELENZA is normally not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

How and where should I store RELENZA?

RELENZA should be stored at room temperature below 77°F (25°C). RELENZA is not in a childproof container. Keep RELENZA out of the reach of children. Discard the DISKHALER after finishing your treatment.

PATIENT INSTRUCTIONS FOR USE

RELENZA logo
(click image for full-size original)

IMPORTANT: Read Step-by-Step Instructions before using the DISKHALER®.

Be sure to take the dose your healthcare provider has prescribed.

BEFORE YOU START:

Please read the entire Patient Labeling for important information about the effects of RELENZA including the section “Important Safety Information About RELENZA” for information about the risk of breathing difficulties.

If RELENZA is prescribed for a child, dosing should be supervised by an adult who understands how to use RELENZA and has been instructed in its use by a healthcare provider.

Parts of the DISKHALER
(click image for full-size original)

Step-by-step instructions for using the DISKHALER®

Step A: Load the medicine into the DISKHALER

  1. Start by pulling off the blue cover.
  2. Always check inside the mouthpiece to make sure it is clear before each use. If foreign objects are in the mouthpiece, they could be inhaled and cause serious harm.
  3. Pull the white mouthpiece by the edges to extend the white tray all the way.
  4. Once the white tray is extended all the way, find the raised ridges on each side of it. Press in these ridges, both sides at the same time, and pull the whole white tray out of the DISKHALER body.
  5. Place one silver medicine disk onto the dark brown wheel, flat side up. The four silver blisters on the underside of the medicine disk will drop neatly into the four holes in the wheel.
  6. Push in the white tray as far as it will go. Now the DISKHALER is loaded with medicine.
Step A: Steps 1, 2, 3, 4, 5, and 6
(click image for full-size original)

Step B: Puncture the blister

Be sure to keep the DISKHALER level.

The DISKHALER punctures one blister of medicine at a time so you can inhale the right amount. It does not matter which blister you start with. Check to make sure that the silver foil is unbroken.

  1. Be sure to keep the DISKHALER level so the medicine does not spill out.
  2. Locate the half-circle flap with the name “RELENZA” on top of the DISKHALER.
  3. Lift this flap from the outer edge until it cannot go any farther. Flap must be straight up for the plastic needle to puncture both the top and bottom of the silver medicine disk inside.
  4. Keeping the DISKHALER level, click the flap down into place.
Step B: Steps 1, 2, 3, and 4
(click image for full-size original)

Step C: Inhale

  1. Before putting the white mouthpiece into your mouth, breathe all the way out (exhale).

    Then put the white mouthpiece into your mouth. Be sure to keep the DISKHALER level so the medicine does not spill out.

  2. Close your lips firmly around the mouthpiece. Be sure not to cover the small holes on either side of it.
  3. Breathe in through your mouth steadily and as deeply as you can. Your breath pulls the medicine into your airways and lungs.
  4. Hold your breath for a few seconds to help RELENZA stay in your lungs where it can work.

To take another inhalation, move to the next blister by following Step D below.

Once you’ve inhaled the number of blisters prescribed by your healthcare provider, replace the cover until your next dose.

Step C: Steps 1 and 2
(click image for full-size original)

Step D: Move the medicine disk to the next blister

  1. Pull the mouthpiece to extend the white tray, without removing it.
  2. Then push it back until it clicks. This pull-push motion rotates the medicine disk to the next blister.
  3. To take your next inhalation, repeat Steps B and C.

If all four blisters in the medicine disk have been used, you are ready to start a new medicine disk (see Step A). Check to make sure that the silver foil is unbroken each time you are ready to puncture the next blister.

Step D: Steps 1 and 2
(click image for full-size original)

IMPORTANT INSTRUCTIONS

Read this entire leaflet before using RELENZA. Even if you have had a previous prescription for RELENZA, read this leaflet to see if any information has changed.

If you have the flu, the usual dose is 2 inhalations twice daily. To reduce the chance of getting the flu, the usual dose is 2 inhalations once daily. However, you must take the number of inhalations your healthcare provider has prescribed.

If you feel worse or develop new symptoms during or after treatment, or if your flu symptoms do not start to improve, stop using the medicine and contact your healthcare provider.

Keep out of reach of children.

Always check inside the mouthpiece to make sure it is clear before each use. If foreign objects are in the mouthpiece, they could be inhaled and cause serious harm.

Always replace the cover after each use.

Throw away the DISKHALER after treatment is completed.

This DISKHALER is for use only with RELENZA. Do not use the RELENZA DISKHALER device with FLOVENT® (fluticasone propionate) and do not use RELENZA with the FLOVENT DISKHALER device.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).

REMEMBER: This medicine has been prescribed for you by your healthcare provider. DO NOT give this medicine to anyone else.

RELENZA, FLOVENT, ROTADISK, and DISKHALER are registered trademarks of GlaxoSmithKline.

FLUMIST is a registered trademark of MedImmune, Inc.

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